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Trial record 72 of 1364 for:    rural

Pharmacist Interventions in Rural Elderly Warfarin Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212898
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Slaven Falamić

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
Time in therapeutic range (TTR) [ Time Frame: 6 months ]
Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Adverse drug reactions [ Time Frame: 6 months ]
    To measure the difference in number and types of adverse drug reactions between the intervention and the control group
  • Time to adverse drug reaction [ Time Frame: 6 months ]
    To measure the difference in time to adverse drug reactions between the intervention and the control group
  • International randomised ratio [ Time Frame: 6 months ]
    To measure the difference in patterns of the International randomised ratio between the intervention and the control group
  • Adherence [ Time Frame: 6 months ]
    To measure the difference in adherence between the intervention and the control group
  • Quality of life [ Time Frame: 6 months ]
    To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire)
  • Incidence and influence of clinically significant drug interactions [ Time Frame: 6 months ]
    To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group
  • Dietary intake of vitamin K [ Time Frame: 6 months ]
    Changes of dietary intake of vitamin K
  • Acceptance of pharmacist's intervention by the general practitioners [ Time Frame: 6 months ]
    To measure the rate of acceptance of pharmacist's interventions by the general practitioners
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacist Interventions in Rural Elderly Warfarin Patients
Official Title  ICMJE The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
Brief Summary The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Atrial Fibrillation
  • Thrombosis
  • Cardiac Failure
  • Hemorrhage
Intervention  ICMJE Other: anticoagulation care
Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin
Study Arms  ICMJE
  • Experimental: Intervention
    Specific pharmacist-led anticoagulation care
    Intervention: Other: anticoagulation care
  • No Intervention: Control
    The control group will receive usual care; no interventions will be administered.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2017)
131
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥65 years
  • Living site of participant outside the city eg. rural site
  • Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before

Exclusion Criteria:

  • Hospitalization
  • Vegetarianism
  • Patients not able to provide an informed consent
  • The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03212898
Other Study ID Numbers  ICMJE SFalamic
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Slaven Falamić
Study Sponsor  ICMJE Slaven Falamić
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Slaven Falamić, MPharm Pharmacy Branka Marušić
PRS Account Slaven Falamić
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP